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Non-invasive Early Goal Directed Therapy in Colorectal Surgery: a Feasibility Study

NCT02559141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-10-29

No results posted yet for this study

Summary

The Nexfin monitoring system offers a complete non-invasive approach to a continuously estimation of blood pressure, CI and PPV by means of finger-cuff based pulse contour analysis. Several clinical investigations have proven reliability and interchangeability of the Nexfin technology yielding acceptable results especially regarding the trending abilities. At present there is no evidence available, whether a early goal directed hemodynamic optimization protocol based on a completely non-invasive monitoring technology is able to reduce postoperative complication. Therefore, the aim of this single-center study is to compare the clinical outcome and postoperative complications of patients undergoing major colorectal surgery treated with standard of care or with a GDT protocol based on the Nexfin technology.

Conditions

  • Perioperative/Postoperative Complications
  • C.Surgical Procedure; Digestive System

Interventions

DRUG

Dobutamine

If PPV ≤10%, volume substitution of 500 ml of crystalloids and/or colloids as long as CI was ≥2.5 l/min/m². Maintenance of CI ≥2.5 l/min/m² and MAP ≥65 mmHg was achieved by using dobutamine (10 µg/kg/min) and norepinephrine (0.03 µg/kg/min).

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02559141 on ClinicalTrials.gov